510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963801Substantially Equivalent

Pap Brush

Young OU Brush Co., Kyong Buk, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963801 is the FDA 510(k) clearance record for PAP BRUSH, a class II device, cleared for Young OU Brush Co. on under FDA product code HHT (Spatula, Cervical, Cytological). FDA records list one 510(k) clearance for Young OU Brush Co. As of , FDA records show no recalls naming K963801.

Clearance record

Decision date
Received
(198 days to decision)
Product code
HHT Spatula, Cervical, Cytological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Young OU Brush Co. 966-114 Kang Keun-Dong, Kyong Buk, KR
510(k) summary
Statement
Third party review
No

Clearances, product code HHT

Trailing 12 months

FDA records hold no clearances under product code HHT in the trailing twelve months.

FDA records show no clearances under product code HHT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260